New drug duo aims to outsmart EGFR-mutant lung cancer

NCT ID NCT07680790

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jul 02, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether adding an experimental drug called izalontamab brengitecan to the standard targeted therapy osimertinib works better than osimertinib alone or with chemotherapy for people with advanced EGFR-mutant non-small cell lung cancer who have not had prior treatment. About 850 participants will be randomly assigned to one of three groups. The main goal is to see if the combination delays cancer growth longer than the current options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: izalontamab brengitecan (also called BMS-986507 or BL-B01D1) combined with osimertinib
What this could lead to: If successful, this combination could become a new first-line treatment option that delays cancer progression better than current therapies for people with EGFR-mutant lung cancer.
What could go wrong: This is an early-phase 3 trial, so results may not confirm benefit. Adding a second drug also raises the chance of side effects, and the experimental drug izalontamab brengitecan has unknown long-term safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 850 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment * Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution) * Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator * Participants must have ECOG Performance Status 0-1 Exclusion Criteria: * Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression * Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis * Participants must not have clinically significant cardiac disease * Other protocol-defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

208 sites in 16 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Local Institution - 0001

Munich, Bavaria, 81377, Germany
Local Institution - 0003

Ankara, 6800, Turkey (Türkiye)
Local Institution - 0008

Ankara, 6680, Turkey (Türkiye)
Local Institution - 0012

Toronto, Ontario, M4N3M5, Canada
Local Institution - 0014

Adana, 1060, Turkey (Türkiye)
Local Institution - 0015

Antalya, 07100, Turkey (Türkiye)
Local Institution - 0019

Adana, 1370, Turkey (Türkiye)
Local Institution - 0021

Sur, Diyarbakır, 21200, Turkey (Türkiye)
Local Institution - 0037

Izmir, 35530, Turkey (Türkiye)
Local Institution - 0039

Istanbul, 34295, Turkey (Türkiye)
Local Institution - 0040

Regina, Saskatchewan, S4T1A5, Canada
Local Institution - 0041

Istanbul, 34214, Turkey (Türkiye)
Local Institution - 0043

Oshawa, Ontario, L1G2B9, Canada
Local Institution - 0045

Toronto, Ontario, M5G2M9, Canada
Local Institution - 0050

Izmir, 35110, Turkey (Türkiye)
Local Institution - 0056

Vancouver, British Columbia, V5Z4E6, Canada
Local Institution - 0057

Montreal, Quebec, H4A3J1, Canada
Local Institution - 0058

Montreal, Quebec, H3T1E2, Canada
Local Institution - 0059

Edmonton, Alberta, T6G1Z2, Canada
Local Institution - 0062

Bron, Rhône, 69677, France
Local Institution - 0063

Dijon, Côte-D'Or, 21079, France
Local Institution - 0064

La Tronche, Nan, 38700, France
Local Institution - 0066

Caen, 14076, France
Local Institution - 0069

Villejuif, Val-De-Marne, 94805, France
Local Institution - 0070

Toulouse, 31059, France
Local Institution - 0071

Paris, Île-de-France Region, 75248, France
Local Institution - 0073

Brest, 29200, France
Local Institution - 0074

Marseille, Bouches-Du-Rhône, 13915, France
Local Institution - 0075

Nantes, Loire Atlantique, 44093, France
Local Institution - 0077

Mar del Plata, Buenos Aires, B7602CBM, Argentina
Local Institution - 0078

Buenos Aires, C1426AGE, Argentina
Local Institution - 0085

Buenos Aires, C1280AEB, Argentina
Local Institution - 0086

Buenos Aires, C1122AAL, Argentina
Local Institution - 0087

Milan, 20141, Italy
Local Institution - 0088

Verona, 37126, Italy
Local Institution - 0089

Milan, 20133, Italy
Local Institution - 0091

Pavia, 27100, Italy
Local Institution - 0093

Bergamo, 24128, Italy
Local Institution - 0094

Candiolo, Turin, 10060, Italy
Local Institution - 0100

Cologne, North Rhine-Westphalia, 50937, Germany
Local Institution - 0101

Münster, North Rhine-Westphalia, 48149, Germany
Local Institution - 0103

Dresden, Saxony, 1307, Germany
Local Institution - 0104

Essen, North Rhine-Westphalia, 45147, Germany
Local Institution - 0105

Regensburg, Bavaria, 93053, Germany
Local Institution - 0106

Oldenburg, Lower Saxony, 26121, Germany
Local Institution - 0108

Großhansdorf, Schleswig-Holstein, 22927, Germany
Local Institution - 0109

Paris, Nan, 75014, France
Local Institution - 0110

Wangen, Baden-Wurttemberg, 88239, Germany
Local Institution - 0111

Ulm, Baden-Wurttemberg, 89081, Germany
Local Institution - 0112

Gerlingen, Baden-Wurttemberg, 70839, Germany
Local Institution - 0116

Lyon, Nan, 69373, France
Local Institution - 0117

Hemer, North Rhine-Westphalia, 58675, Germany
Local Institution - 0121

Yokohama, Kanagawa, 241-8515, Japan
Local Institution - 0122

Sendai, Miyagi, 980-0873, Japan
Local Institution - 0123

Songpa-Gu, Seoul, 138-736, South Korea
Local Institution - 0124

Seocho -Gu, Seoul, 6591, South Korea
Local Institution - 0125

Hirakata-Shi, Osaka, 573-1191, Japan
Local Institution - 0126

Seoul, 8308, South Korea
Local Institution - 0127

Goyang-si, Gyeonggi-do, 410-769, South Korea
Local Institution - 0128

Toon-Shi, Ehime, 791-0295, Japan
Local Institution - 0129

Osakasayama-Shi, Osaka, 589-8511, Japan
Local Institution - 0131

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Local Institution - 0133

Seongnam-si, Gyeonggi-do, 13620, South Korea
Local Institution - 0134

Hwasun-Gun, Jeollanam-do, 58128, South Korea
Local Institution - 0135

Seoul, 120-752, South Korea
Local Institution - 0136

Kurume-Shi, Fukuoka, 830-0011, Japan
Local Institution - 0137

Chūōku, Tokyo-To, 104-0045, Japan
Local Institution - 0138

Buk-Gu, Daegu, 41404, South Korea
Local Institution - 0139

Gyeongsangnam-do, 050612, South Korea
Local Institution - 0140

Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644, South Korea
Local Institution - 0141

Hamamatsu, Shizuoka, 431-3192, Japan
Local Institution - 0143

Majadahonda, Madrid, 28222, Spain
Local Institution - 0144

Jaén, 23007, Spain
Local Institution - 0147

Seville, Seville, 41013, Spain
Local Institution - 0148

Madrid, 28041, Spain
Local Institution - 0149

Jerez de la Frontera, 11407, Spain
Local Institution - 0150

Málaga, 29010, Spain
Local Institution - 0151

Buenos Aires, C1426ANZ, Argentina
Local Institution - 0153

New York, New York, 10021, United States
Local Institution - 0157

The Bronx, New York, 10461, United States
Local Institution - 0165

Fairfax, Virginia, 22031, United States
Local Institution - 0183

New Brunswick, New Jersey, 08901, United States
Local Institution - 0199

Memphis, Tennessee, 38120, United States
Local Institution - 0200

Sioux Falls, South Dakota, 57105, United States
Local Institution - 0207

Ottawa, Illinois, 61350, United States
Local Institution - 0210

Honolulu, Hawaii, 96813, United States
Local Institution - 0212

Beverly Hills, California, 90211, United States
Local Institution - 0215

Pune, Maharashtra, 411013, India
Local Institution - 0216

Taipei, Taichung, 112, Taiwan
Local Institution - 0221

Taoyuan City, Taoyuan, 33378, Taiwan
Local Institution - 0222

Chennai, Tamil Nadu, 600035, India
Local Institution - 0223

Taipei City, Taipei, 106, Taiwan
Local Institution - 0225

Vadodara, Gujarat, 361790, India
Local Institution - 0226

Jaén, 23007, Spain
Local Institution - 0227

Gaoxiongka, Taiwan, 807, Taiwan
Local Institution - 0229

Kaohsiung City, Kaohsiung, 82445, Taiwan
Local Institution - 0230

New Taipei City, New Taipei, 23561, Taiwan
Local Institution - 0233

Mohali, Punjab, 140901, India
Local Institution - 0236

Meldola, Forli-Cesena, 47014, Italy
Local Institution - 0238

Milan, 20142, Italy
Local Institution - 0239

Lübeck, Schleswig-Holstein, 23538, Germany
Local Institution - 0241

Valencia, 46009, Spain
Local Institution - 0242

A Coruña, 15006, Spain
Local Institution - 0243

Dortmund, North Rhine-Westphalia, 44263, Germany
Local Institution - 0244

Barretos, São Paulo, 14784-400, Brazil
Local Institution - 0247

Ijuí, Rio Grande do Sul, 98700-000, Brazil
Local Institution - 0249

Campinas, São Paulo, 13060-803, Brazil
Local Institution - 0252

Florianópolis, Santa Catarina, 88020, Brazil
Local Institution - 0253

Vitória, Espírito Santo, 29043-260, Brazil
Local Institution - 0255

Rio de Janeiro, 20230-130, Brazil
Local Institution - 0259

São Paulo, 01246-000, Brazil
Local Institution - 0261

Sorocaba, São Paulo, 18030-005, Brazil
Local Institution - 0262

Nagoya, Aichi-ken, 464-8681, Japan
Local Institution - 0265

Pendik, Istanbul, 34340, Turkey (Türkiye)
Local Institution - 0275

Bangkok, Bangkok, 10300, Thailand
Local Institution - 0283

Seattle, Washington, 98104, United States
Local Institution - 0289

Brescia, 25123, Italy
Local Institution - 0290

Lebanon, New Hampshire, 03756, United States
Local Institution - 0291

Salvador, Estado de Bahia, 40170-110, Brazil
Local Institution - 0298

Anyang, Henan, 455000, China
Local Institution - 0306

Changsha Shi, Hunan, 410013, China
Local Institution - 0312

Hangzhou, Zhejiang, 310022, China
Local Institution - 0316

Taiyuan, Shanxi, 30001, China
Local Institution - 0319

Shanghai Shi, Shanghai Municipality, 200120, China
Local Institution - 0320

Dazhou Shi, Sichuan, 635000, China
Local Institution - 0321

Guilin, Guangxi, 541199, China
Local Institution - 0322

Shijiazhuang, Hebei, 050035, China
Local Institution - 0326

Dongguan Shi, Guangdong, 523059, China
Local Institution - 0328

Nanning, Guangxi, 530021, China
Local Institution - 0330

Haikou, Hainan, 570000, China
Local Institution - 0331

Guangzhou, Guangdong, 510080, China
Local Institution - 0332

Shenyang, Liaoning, 110042, China
Local Institution - 0337

Gurgaon, Haryana, 122001, India
Local Institution - 0341

Weihui Shi, Henan, 453100, China
Local Institution - 0343

Harbin, Heilongjiang, 150081, China
Local Institution - 0347

Nanjing, Jiangsu, 210029, China
Local Institution - 0357

La Jolla, California, 92093, United States
Local Institution - 0364

Saint Paul, Minnesota, 55102, United States
Local Institution - 0366

Orlando, Florida, 32806, United States
Local Institution - 0385

Charlotte, North Carolina, 28204, United States
Local Institution - 0402

Omaha, Nebraska, 68198, United States
Local Institution - 0403

St Louis, Missouri, 63110, United States
Local Institution - 0404

Portland, Oregon, 97213, United States
Local Institution - 0407

Laval, Quebec, H7M3L9, Canada
Local Institution - 0411

Salt Lake City, Utah, 84112, United States
Local Institution - 0412

Leipzig, Saxony, 4103, Germany
Local Institution - 0413

Linyi, Shandong, 276027, China
Local Institution - 0414

Kōtoku, Tokyo-To, 135-8550, Japan
Local Institution - 0418

Taichung, 402, Taiwan
Local Institution - 0419

Taipei, 10002, Taiwan
Local Institution - 0420

Tainan, 70428, Taiwan
Local Institution - 0423

Zhengzhou, Henan, 450008, China
Local Institution - 0424

Camperdown, New South Wales, 2050, Australia
Local Institution - 0432

Buenos Aires, C1199ABB, Argentina
Local Institution - 0433

Okayama, Okayama-ken, 700-8558, Japan
Local Institution - 0436

Belagavi, Karnataka, 590010, India
Local Institution - 0437

Murdoch, Western Australia, 6150, Australia
Local Institution - 0438

Sandusky, Ohio, 44870, United States
Local Institution - 0439

Westmead, New South Wales, 2145, Australia
Local Institution - 0444

Badsa, Haryana, 124105, India
Local Institution - 0445

Giessen, 35392, Germany
Local Institution - 0446

Frankfurt am Main, Hesse, 60389, Germany
Local Institution - 0447

Clayton, Victoria, 3168, Australia
Local Institution - 0450

Wuhan, Hubei, 430022, China
Local Institution - 0452

Tianjin, Tianjin Municipality, 300060, China
Local Institution - 0455

Jinan, Shandong, 250117, China
Local Institution - 0456

Chengdu, Sichuan, 610041, China
Local Institution - 0457

Fuzhou, Fujian, 350014, China
Local Institution - 0458

Beijing, Beijing Municipality, 101149, China
Local Institution - 0463

Taiyuan, Shanxi, 30013, China
Local Institution - 0464

Xi'an, Shaanxi, 710038, China
Local Institution - 0467

Changsha, Hunan, 410008, China
Local Institution - 0469

Weifang Shi, Shandong, 261000, China
Local Institution - 0470

Chongqing, Chongqing Municipality, 400030, China
Local Institution - 0471

Chengdu, Sichuan, 610041, China
Local Institution - 0472

Yibin, Sichuan, 644000, China
Local Institution - 0478

Zhongshan, Guangdong, 528403, China
Local Institution - 0479

Binzhou, Shandong, 256603, China
Local Institution - 0480

Zhengzhou, Henan, 450000, China
Local Institution - 0482

Changsha, Hunan, 410007, China
Local Institution - 0483

Jingzhou, Hubei, 0, China
Local Institution - 0487

Easton, Pennsylvania, 18045, United States
Local Institution - 0492

Adelaide, South Australia, 5000, Australia
Local Institution - 0493

Fuzhou, Fujian, 350001, China
Local Institution - 0494

Abbotsford British Columbia, British Columbia, V2S0C2, Canada
Local Institution - 0502

Morgantown, West Virginia, 26505, United States
Local Institution - 0503

Baltimore, Maryland, 21202, United States
Local Institution - 0504

Fullerton, California, 92835, United States
Local Institution - 0505

Guiyang, Guizhou, 550003, China
Local Institution - 0506

Dalseo, Daegu, 42601, South Korea
Local Institution - 0511

Greenslopes, Queensland, 4120, Australia
Local Institution - 0512

Jiangmen, Guangdong, 0, China
Local Institution - 0514

Río Cuarto, Córdoba Province, 5800, Argentina
Local Institution - 0517

Beijing, Beijing Municipality, 100142, China
Local Institution - 0519

Palm Bay, Florida, 32901, United States
Local Institution - 0520

Pueblo, Colorado, 81003, United States
Local Institution - 0521

Edina, Minnesota, 55435, United States
Local Institution - 0522

Beaumont, Texas, 77702, United States
Local Institution - 0523

Silver Spring, Maryland, 20904, United States
Local Institution - 0524

West Palm Beach, Florida, 33401, United States
Local Institution - 0525

Dallas, Texas, 75246, United States
Local Institution - 0526

St. Petersburg, Florida, 33701, United States
Local Institution - 0527

Fort Myers, Florida, 33901, United States
Local Institution - 0528

Winchester, Virginia, 22601, United States
Local Institution - 0529

San Antonio, Texas, 78217, United States
Local Institution - 0530

Fairfax, Virginia, 22031, United States
Local Institution - 0531

Lianyungang, Jiangsu, 222061, China
Local Institution - 0533

Oakville, Ontario, L6M 0L8, Canada

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